Job Description

Job Summary

The QA Project Manager is responsible for providing dedicated project management support for a complex, site-wide remediation program. This role partners closely with Quality leadership to drive execution of remediation activities, maintain oversight of the integrated project plan, coordinate resources across multiple workstreams, and ensure timely completion of key deliverables. The position serves as a central point of coordination, facilitating cross-functional collaboration, managing dependencies and risks, and driving accountability to ensure remediation commitments are executed effectively and on schedule.

This role requires strong project management expertise, exceptional organizational skills, and the ability to influence and coordinate stakeholders across Quality, Manufacturing, Engineering, Validation, Regulatory Affairs, Supply Chain, and other functional areas.

Salary Range: $110,000 - $130,000

• Position is eligible to participate in a bonus plan with a target of 10% of the base salary
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

Program and Project Management

• Provide day-to-day project management support for the Phase 2 remediation program.
• Develop, maintain, and continuously update the integrated remediation project plan.
• Coordinate project activities across multiple remediation workstreams to ensure alignment with overall program objectives and timelines.
• Monitor project progress and proactively identify schedule risks, resource constraints, and execution challenges.
• Facilitate resolution of issues and escalation of risks as appropriate to ensure project milestones remain on track.
• Support the development and maintenance of project governance processes, reporting mechanisms, and project documentation.

Cross-Functional Coordination

• Act as a liaison between Quality, Manufacturing, Engineering, Validation, Regulatory Affairs, and other stakeholder groups.
• Coordinate project meetings, working sessions, and governance reviews.
• Ensure alignment among workstream leads regarding timelines, priorities, deliverables, and resource requirements.
• Drive accountability across teams by tracking commitments and following up on outstanding actions.

Action Item and Deliverable Management

• Establish and maintain action item tracking systems for remediation activities.
• Monitor progress against commitments and ensure timely completion of assigned tasks.
• Track critical deliverables, milestones, and interdependencies across workstreams.
• Identify potential delays and coordinate mitigation plans with stakeholders.
• Maintain accurate records of project decisions, action items, and status updates.

Risk and Dependency Management

• Identify and assess project risks and dependencies that may impact program execution.
• Facilitate risk mitigation planning and monitor effectiveness of mitigation activities.
• Ensure dependencies across remediation workstreams are clearly understood and actively managed.
• Escalate significant risks, barriers, or resource issues to leadership as needed.

Reporting and Communication

• Prepare project status reports, dashboards, and executive updates.
• Provide regular updates on project performance, milestone achievement, and remediation progress.
• Develop presentations and communication materials for leadership review meetings.
• Support audit, regulatory, and inspection readiness efforts through accurate project documentation and status reporting.

Job Requirements

• Bachelor's degree in Life Sciences, Engineering, Quality, Business, Project Management, or a related field required.
• Project Management Professional (PMP) certification preferred.
• 5+ years of project management experience in a highly regulated industry such as pharmaceuticals, biologics, medical devices, or manufacturing.
• Experience leading complex, cross-functional projects involving Quality systems, compliance initiatives, remediation programs, or operational excellence initiatives.
• Demonstrated success managing integrated project plans, timelines, budgets, and stakeholder communications.
• Experience supporting regulatory inspections, audits, CAPA programs, or quality remediation activities.
• Strong understanding of Quality systems, GMP requirements, and regulatory compliance principles.
• Advanced project planning, scheduling, and program management capabilities.
• Exceptional organizational and prioritization skills with strong attention to detail.
• Ability to manage multiple workstreams and competing priorities simultaneously.
• Strong facilitation, communication, and stakeholder management skills.
• Proficiency with project management tools such as Microsoft Project, Smartsheet, Planview, or similar platforms.
• Ability to influence without direct authority and effectively build relationships across organizational levels.
• Strong analytical, problem-solving, and risk management capabilities.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.